What did the FDCA of 1938 accomplish? - ✔✔Food, Drug, and Cosmetic Act
1) Drugs must be safe prior to marketing
2) Established the FDA - Food, Drug, Cosmetic, Medical device safety
Durham-Humphrey Amendment of 1951 -
...
What did the FDCA of 1938 accomplish? - ✔✔Food, Drug, and Cosmetic Act
1) Drugs must be safe prior to marketing
2) Established the FDA - Food, Drug, Cosmetic, Medical device safety
Durham-Humphrey Amendment of 1951 - ✔✔• Created a distinction between "OTC"
and "Legend Drugs/Prescription".
• Authorized verbal prescriptions/refills
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
Kefauver-Harris Amendment of 1962 - ✔✔1) Requires all medications in US to be pure
safe and effective.
2) Established the Good Manufacturing Practices (currentGMPs)
Prescription Drug Marketing Act of 1987 (PDMA) - ✔✔1) Prevents re-importation of a
drug into US.
2) Prohibited hospital and healthcare entities from reselling their pharamaceuticals.
3) Prohibits sale, trade, or purchase of Rx samples
4) "Samples Act"
Drug Compounding Quality and Security Act 2013 (DQSA) - ✔✔1) Outsourcing (503B)
facilities can compound (w/o a prescription) - Regulated by FDA/cGMP
- 503B are exempt from premarket approval, adequate directions for use, and trackand-trace provisions.
Benefits and restrictions of a 503A facility - ✔✔503A facilities can pre-emptively
compound (anticipatory) but only pursuant to a prescription or medication order.
Regulated by states/USP standards
Benefits and restrictions of a 503B facility - ✔✔Outsourcing facility (503B)
Can compound (w/o a prescription)
- Regulated by FDA/cGMP.
- Exempt from: premarket approval, adequate directions for use, and track-and-trace
provisions.
- May not compound a bulk drug unless on a shortage or bulk list.
Requirements of a 503B facility - ✔✔1) Licensed pharmacist to provide direct oversight
2) Register with the FDA as an outsourcing facility
3) Report to HHS every 6 months
4) Report serious adverse events w/in 15 days
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